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Elagolix/estradiol/norethisterone acetate
Combination drug From Wikipedia, the free encyclopedia
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Elagolix/estradiol/norethisterone acetate, sold under the brand name Oriahnn, is a fixed-dose combination medication used to treat heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.[1][2][3] It contains elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethisterone acetate, a progestin.[1][2] It is taken by mouth.[1][2] Oriahnn is co-packaged as a combination of elagolix/estradiol/norethisterone acetate capsules with elagolix capsules.[1]
The most common side effects include hot flushes (sudden feelings of warmth), headache, fatigue and irregular vaginal bleeding.[2]
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Medical uses
Fibroids are benign (non-cancerous) muscle tumors of the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems and infertility.[2] Some women may not experience any symptoms, but many do, including heavy bleeding with periods.[2] Fibroids can occur at any age but are most common in women 35 to 49 years of age.[2] They typically resolve after menopause but are a leading reason for hysterectomy (surgical removal of the uterus) in the United States when they cause severe symptoms.[2]
Elagolix/estradiol/norethisterone acetate is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.[2]
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Adverse effects
Elagolix/estradiol/norethisterone acetate may cause bone loss over time, and the loss in some women may not be completely recovered after stopping treatment.[2] Because bone loss may increase the risk for fractures, women should not take elagolix/estradiol/norethisterone acetate for more than 24 months.[2]
The drug label for the combination includes a boxed warning about the risk of vascular events (strokes) and thrombotic or thromboembolic disorders (blood clots), especially in women at increased risk for these events.[2]
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History
Elagolix/estradiol/norethisterone acetate was approved for medical use in the United States in May 2020.[2][4]
The efficacy of elagolix/estradiol/norethisterone acetate was established in two clinical trials in which a total of 591 premenopausal women with heavy menstrual bleeding received the drug or placebo for six months.[2] Heavy menstrual bleeding at baseline was defined as having at least two menstrual cycles with greater than 80 mL (about a third of a cup) of menstrual blood loss (MBL).[2] The primary endpoint was the proportion of women who achieved MBL volume less than 80 mL at the final month and 50% or greater reduction in MBL volume from the start of the study (baseline) to the final month.[2] In the first study, 68.5% of participants who received elagolix/estradiol/norethisterone acetate achieved this endpoint (compared to 8.7% of participants who received placebo).[2] In the second study, 76.5% of participants who received elagolix/estradiol/norethisterone acetate achieved this endpoint (compared to 10.5% of participants who received placebo).[2]
The approval of Oriahnn was granted to AbbVie Inc.[2]
References
External links
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